Clinical Trial: Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.

Brief Summary: Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.

Detailed Summary:
Sponsor: Ludwig Boltzmann Gesellschaft

Current Primary Outcome: Cardiac output measured by a transesophageal probe [ Time Frame: 48 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in mixed venous saturation [ Time Frame: 48 hours ]
  • Serum lactate levels [ Time Frame: 48 hours ]
  • Cardiac output and ventricular function assessed by echocardiography [ Time Frame: 48 hours ]
  • Mean arterial, left atrial and central venous pressure [ Time Frame: 48 hours ]
  • Need of catecholamines assessed with the inotropic score [ Time Frame: 48 hours ]
  • Urine output [ Time Frame: 48 hours ]


Original Secondary Outcome: Same as current

Information By: Ludwig Boltzmann Gesellschaft

Dates:
Date Received: October 24, 2007
Date Started: September 2007
Date Completion:
Last Updated: October 24, 2007
Last Verified: October 2007